TCS Daily

Europe's REACH Exceeds Its Scientific Grasp

By Henry I. Miller - August 28, 2003 12:00 AM

European regulatory officials have raised hostility to technological innovation to an art form.  Their current medium of choice is the precautionary principle, which holds that as long as the evidence about the safety of a product, technology or activity is in any way incomplete, it should be prohibited or, at the least, heavily regulated.

Supposedly a variation on the motherly admonition of "better safe than sorry," the "principle" is not really one at all, but only a fig leaf for dubious decision-making whose basis may be ideological or protectionist.  It enables regulators to delay or deny new products, technologies, or activities on the basis of no more than conjecture about possible dangers. 

The latest manifestation of the precautionary principle in Europe is a new proposal that comes in response to pressure from radical environmental groups that campaign relentlessly against the use of chemicals.  Dubbed REACH, for Registration, Evaluation and Authorization of Chemicals, the proposal is far-reaching.  Its registration requirement compels manufacturers and importers to submit information to a central database on hazard, exposure, and risk on 30,000 new and existing substances that are produced or imported in yearly quantities exceeding 1 metric ton.  Evaluation requires regulators to assess risks for 5,000 substances that are produced or imported in yearly quantities exceeding 100 tons, and also for substances in lower quantities if they are "of concern." The newly established European Chemicals Agency will then determine if further testing is needed. Authorization applies to substances of "very high concern," for which specific permission would be required for certain uses.  Approximately 1400, or 5 percent, of registered substances will be subject to authorization.

REACH is applicable not only to the 30,000 specifically referenced chemicals, but also to the "downstream" products, which are widely used by consumers and business of all sorts, that contain these chemicals.  It requires downstream users to carry out additional testing if the exposure or use of the product exceeds that foreseen by the manufacturer.  Because chemical products are ubiquitous in automobiles, aircraft, home construction and furnishings, and workplaces, REACH intrudes deeply into the life of every European. 

The regime is ill considered, anti-innovative, hugely expensive and protectionist.  The testing of chemicals for which there is evidence or suspicion of toxicity may be sensible, but testing all - including those for which there is no evidence of any harm even at high exposures -- diverts attention from more dangerous compounds.  Instead of focusing on the development of new, innovative products, corporate scientists will be preoccupied with gratuitous testing of chemicals known to be safe in normal use. 

The REACH proposal establishes a "duty of care" for manufacturers, importers and downstream users, supposedly to assure that chemical substances do not cause adverse health and environmental impacts, but it fails to clarify how that duty of care might be met.  The language suggests that any adverse impact from a chemical substance, including alleged harm from a substance contained in a finished good or article, is sufficient to subject the manufacturer, importer and/or downstream user to liability.  In effect, the duty of care provision implies that any activity involving chemicals is so hazardous that it requires the manufacturer, importer or downstream user to ensure absolute safety or face significant consequences. Placing the burden of proof on those who manufacture or use chemicals, instead of on those who claim to be injured, has ominous implications for liability suits.

The REACH proposal is a threat to the chemical industry in other ways.  For example, the draft regulation requires the disclosure of detailed information about various applications of chemicals, to governments, upstream and downstream suppliers, and the public.  However, the details of those specific applications (e.g., the chemicals that confer a desirable characteristic, that are used to "finish" a product) often are the proprietary information of companies, especially small and medium sized enterprises.

The proposal places undue emphasis on the precautionary principle's currently trendy category, so-called "endocrine disrupters" - environmental chemicals that allegedly exert hormonal effects on humans. The proposal incorrectly defines "endocrine disruption," per se, as an adverse health effect.  The reality is that although some kinds of interference with hormonal (that is, endocrine) processes may lead to an adverse health outcome, endocrine disruption is not itself one; a bona fide "adverse effect" must be scientifically demonstrated before a substance can be labeled (and stigmatized) as an "endocrine substance of concern."  (Otherwise, soy products, which exert mild estrogenic effects, or sugar, which stimulates insulin release from the pancreas, could fall into this category.) 

Various kinds of health effects of new chemicals are now already routinely evaluated by manufacturers, with genuine adverse effects identified as carcinogenic (cancer-causing), mutagenic (inducing mutations), or teratogenic (causing birth defects).

Finally, the expense will be monumental.  The EC itself has (very) conservatively estimated that the direct and indirect costs of the new system will be €18 to 32 billion, and various independent assessments predict near-catastrophic macroeconomic effects: For example, the estimated impact on France's GDP by 2012 would be between 1.7 and 3.2 percent, with job losses between 360,000 and 670,000.  Does this sound like an intelligent policy for a region that is already teetering on the brink of economic recession?

In short, the REACH proposal reads like something produced by precocious student members of the Ecology Club at a progressive high school - naive, exuberant, excessive, but scientifically flawed and ultimately wrong-headed.

There is something to be said for letting our trade competitors in Europe simply self-destruct from the effects of a massive, self-administered, regulatory overdose.  However, the imposition of such unreasonable requirements will have ominous consequences for companies that wish to export to the European market.  The EU's execrable performance on the regulatory oversight of gene-spliced crops and foods should serve as a reminder that too often Europe's regulatory requirements towards a product seem to be dictated by its country of origin, rather than by its objective characteristics.

Worst of all, the EU is attempting to secure acceptance of the precautionary principle in international agreements and treaties.  Senior EU negotiators, with minions in tow, now turn up at what used to be meetings of technical experts to decide on science-based standards and regulatory requirements.  As these agreements are hammered out, the EU commands and orchestrates the support of its member countries, and also of like-minded NGOs, if they have standing.

The precautionary principle exaggerates the potential drawbacks of new products and underestimates their benefits. The decision-making process it dictates is intentionally weighted against new technologies even after they have been cautiously examined and proven in extensive use. It forces us to ignore proven benefits in a costly effort to eliminate hypothetical risks that are small or easily manageable.  All of this is predicated on the false assumption that little harm comes from delaying the introduction of new products and technologies.

Science writer Colin Tudge, writing in New Scientist, remonstrates that the various manifestations of the precautionary principle "generally include some notion of cost-effectiveness."  Thus, "the point is not simply to ban things that are not known to be absolutely safe. Rather [the precautionary principle] says: 'Of course you can make no progress without risk. But if there is no obvious gain from taking the risk, then don't take it.'"

This reasoning is specious in a couple of ways.  First, it begs the question of how reliably we can quantify hypothetical costs and benefits, especially the future rewards of discoveries and inventions at their inception. Often, the long-term benefits are completely unanticipated, even by the product's developers; the steam engine, electricity and airplane come to mind.  And as science writer Ronald Bailey has pointed out, when the optical laser was invented in 1960, it was dismissed as "an invention looking for a job."  Now, it is ubiquitous, used in applications ranging from surgical scalpels to surveying, telecommunications to tattoo-removal. 

Second, basic research - which, by definition, has no known short-term application - is of inestimable value.  Its pursuit is not only completely legitimate, but also essential to technological progress.  Whether the purpose of an experiment is to test an HIV cure, to evaluate a new adhesive for improved Post-It Notes, or "merely" to elucidate some fundamental question in plant biology, research should not be encumbered without good reason.

In the interest of free markets and economic growth, we need global regulatory policies that make scientific sense and that encourage innovative research and development.  But by promoting the precautionary principle, and by exporting their own version of unscientific and inconsistent regulation, EU politicians are performing a disservice. The only winners will be the European apparatchiks who will enjoy additional power, and the anti-science activists who will have succeeded in erecting yet more barriers to the use of superior technologies and useful products.

European bureaucrats are trying to export the precautionary principle across the Atlantic.  Personally, I'd rather endure Swedish taxes, English food, and Italian air conditioning.

Henry I. Miller, a physician, is a fellow at the Hoover Institution and the Competitive Enterprise Institute. He was an official at the NIH and FDA from 1977-1994.


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